Apparatus and method for applying light in ocular and periocular areas

ABSTRACT

A removable tip for a light energy handpiece comprises a hollow conduit configured to surround a light guide in the handpiece; a support extension having a length longer than a length of the hollow conduit; and a shielding extension coupled to the support extension at an angle less than 180 degrees and located in front of the hollow conduit. The shielding extension is configured to be inserted behind an eyelid and extend to the fornix, the shielding extension comprised of a thermally insulative material.

RELATED APPLICATION

This application is a continuation application of U.S. patentapplication Ser. No. 17/346,254, filed Jun. 13, 2021, which is acontinuation application of U.S. patent application Ser. No. 16/595,711,filed Oct. 8, 2019, now U.S. Pat. No. 11,065,076, issued on Jul. 20,2021, which is a continuation application of U.S. patent applicationSer. No. 16/232,968, filed Dec. 26, 2018, now U.S. Pat. No. 10,478,264,issued on Nov. 19, 2019, which is a continuation application of U.S.patent application Ser. No. 16/117,218, filed Aug. 30, 2018, now U.S.Pat. No. 10,426,564, issued on Oct. 1, 2019, which is a divisionalapplication of U.S. patent application Ser. No. 15/069,660, filed Mar.14, 2016, now U.S. Pat. No. 10,085,814, issued on Oct. 2, 2018, which isa continuation application of U.S. patent application Ser. No.13/707,834, filed Dec. 7, 2012, now U.S. Pat. No. 9,333,370, issued onMay 10, 2016, which claims priority from U.S. Provisional PatentApplication Ser. No. 61/567,859, filed Dec. 7, 2011, the entire contentsof which are hereby incorporated by reference.

BACKGROUND

Light energy sources, whether incoherent such as LEDs or Intense PulsedLight (IPL), or coherent, such as a carbon dioxide (CO2) gas laser,Nd:YAG or Er:YAG solid state lasers, fiber or diode lasers, have beenused for various applications such as surgical, dermatological and/oraesthetic treatments on areas of skin and various external and internalbody organs and tissues. However, using energy sources for applicationto skin surface areas, particularly in the vicinity of the eye, such asthe eyelids and adjacent regions of the face, also referred to as ocularand periocular/circumocular areas, may raise safety concerns. Forexample, heat dissipation from IPL can cause detrimental damage, eithertemporary or permanent, to various ocular structures, such as the corneawhich is the organ responsible for approximately 70% of the human eyerefraction power.

SUMMARY

In one embodiment, a removable tip for an energy light producinghandpiece is provided. The removable tip comprises a hollowconduit/cavity configured to surround a light guide in the handpiece; asupport extension having a length longer than a length of the hollowconduit/cavity; and a shielding extension coupled to the supportextension at an angle less than 180 degrees and located distally to thehollow conduit/cavity. The shielding extension is configured to beinserted behind an eyelid and extend to the fornix, the shieldingextension comprised of a thermally insulative material.

DRAWINGS

Understanding that the drawings depict only exemplary embodiments andare not therefore to be considered limiting in scope, the exemplaryembodiments will be described with additional specificity and detailthrough the use of the accompanying drawings, in which:

FIG. 1 is a block diagram of one embodiment of alight delivery system.

FIG. 2 is a block diagram of one embodiment of a handpiece and handpiecetip.

FIG. 3 is a block diagram of one embodiment of a removable handpiecetip.

FIG. 4 is a block diagram of another embodiment of a removable handpiecetip.

FIG. 5 is a block diagram of yet a further embodiment of a removalhandpiece tip.

FIG. 6 is an exemplary diagram depicting one embodiment of a removabletip placed to protect ocular tissue.

FIG. 7 is a flow chart depicting one embodiment of a method ofprotecting ocular tissue.

In accordance with common practice, the various described features arenot drawn to scale but are drawn to emphasize specific features relevantto the exemplary embodiments.

DETAILED DESCRIPTION

In the following detailed description, reference is made to theaccompanying drawings that form a part hereof, and in which is shown byway of illustration specific illustrative embodiments. However, it is tobe understood that other embodiments may be utilized and that logical,mechanical, and electrical changes may be made. Furthermore, the methodpresented in the drawing figures and the specification is not to beconstrued as limiting the order in which the individual steps may beperformed. The following detailed description is, therefore, not to betaken in a limiting sense.

The embodiments described below enable safe irradiation of regions ofskin covering or surrounding the eye, using various therapeutic energylight sources, such as those mentioned above. In particular, theembodiments described below provide a shield between ocular structuresto be protected and the target tissue as described below. Thus, theembodiments described below provide increased protection of sensitiveocular organs as compared to other systems which rely on externalprotection, such as the system described in U.S. Pat. No. 7,886,748.

FIG. 1 is a high-level diagram of one embodiment of a system 100 fordelivering light energy to ocular and periocular areas. System 100includes a control console 110 and a handpiece 102 coupled to thecontrol console via an umbilical sheath 108. The control console 110 isconfigured to generate energy at levels appropriate for palpebraltreatments. Hence, the control console 110 includes, inter alia,power-supplies and control electronics for components of the handpiece102. The control electronics 112 and power supplies 114 are connected tothe handpiece 102 via the umbilical sheath 108.

The handpiece 102 may include a light guide or crystal 120 for directingthe light energy. Handpiece 102 may include an internal light sourcewhich is controlled by the control console 110. Internal light sourcesmay be of different types such as LEDs, lamps, diode lasers, fiberlasers or solid state lasers, to name but a few. Multiple sources,whether from the same type or from different types, may be combined intoa single handpiece. Light sources located within handpiece 102 have theadvantage of using multiple simple umbilical sheaths 108 lacking opticalcomponents. In yet another configuration, external light sources may beused. External light sources may be solid state lasers, fiber lasers orgas lasers which may be located in control console 110. In thisembodiment, of external light sources, requires the use of an umbilicalsheath 108, which among other things, can deliver the light energy fromcontrol console 110 to the handpiece 102.

The handpiece 102 may include a conduit/cavity 116 configured to guidethe light or accommodate a light guiding element. Different types oflight energy sources, such as those mentioned above, may be guided anddelivered onto the target tissue in different manners. In one embodimentof the present invention, the handpiece may include a lamp which isconfigured to generate an intense pulsed light (IPL). In this embodimenta crystal light guide 120 is placed within the handpiece conduit/cavity116. The crystal light guide 120 may have different lengths and crosssectional geometry. The crystal light guide 120 may have a uniform crosssection or the cross section of the light guide 120 may be tapered inorder to increase the energy fluence at the spot of treatment. The lightguide 120 may also have the same shape and cross section which bestconforms to the target tissue area. For example, the light guide 120 mayhave the same shape as the entire target area so that a single pulse oflight may cover the entire treatment target area. A curved crescent-likeshape is one which may cover the entire lower eyelid. The light guide120 may be permanently affixed to the handpiece or may be removablyaffixed to the handpiece to allow the physician to select the best lightguide 120 suited for the patient and treatment area. The light guide 120may be configured to establish a direct contact with the target tissueor the light guide 120 may treat the target tissue without directcontact. The same light guide 120 may be used in a contact mode or anon-contact mode using an affixing mechanism which supports bothconfigurations.

The light guide 120 may also be configured as a hollowed conduit todeliver light energy in free space to the target tissue. In yet anotherconfiguration the light guide may comprise an optical fiber or a bundleof optical fibers. The handpiece 102 may be configured to move theoptical fiber in a predetermined pattern such that the fiber will scanat least a portion of the target tissue. Or the handpiece 102 may beconfigured to scan a light beam through free space over a target tissueusing controllable optical elements. A beam splitter may be used inorder to create fractional treatment to the target tissue.

The handpiece also includes a removable tip 104. In particular, in someembodiments, the tip 104 is disposable. The size and shape of the tip104 may vary according to the size and shape of the handpiece 102 towhich it is attached. For example, in some embodiments, the tip 104 isconfigured to be compatible with a small handpiece configured forprecise digital manipulation such as the handpiece described in U.S.Pat. No. 7,886,748. However, it is to be understood that other handpieceshapes and configurations can be used in other embodiments. For example,a handpiece having a shape and configuration similar to the handpiecedescribed and shown in U.S. Pat. No. 6,758,845 or U.S. Pat. No. D643530can be used in other embodiments.

The tip 104 is physically equipped with a shielding extension 106 whichprovides protection of sensitive ocular organs. For example, theshielding extension 106 may be configured to create a mechanicalseparation of the target tissue (e.g. an eyelid) from adjacent posteriorstructures (e.g. cornea or sclera) and can be used by a medicalprofessional to create an artificial gap or distance between therespective tissues, as described in more detail below. In addition, theshielding extension 106 is made of or coated with thermally insulativematerials that prevent thermal energy from dissipating or transferringto other structures which are not the intended target tissue.Furthermore, the tip 104 is made from materials that are biocompatiblewith ocular tissue such as, but not limited to, collagen and polymermaterials that are known to one of skill in the art. Hence, the tip 104presents minimal to no risk of abrasive damage to the ocular tissue.FIG. 2 is a block diagram of another embodiment of a handpiece 202. Inthe embodiment of FIG. 2, the control electronics 212, light source 215and handpiece 202 are combined into a small stand-alone hand-held unit.In such a configuration, the umbilical sheath 108 shown in FIG. 1, maybe integrated into the internal electronic circuits of the system andcircuitry of the handpiece 102. In addition, the handpiece 102 includesa heat sink 217 that is thermally coupled to the shielding extension 206vai the support extension 218. In this way, thermal energy can bedissipated via the tip 204 to the heat sink 217. Alternatively, the heatsink 217 can be replaced with a cooling source which is thermallycoupled to the shielding extension 206 via the support extension 216. Inthis embodiment, the cooling source is able to cool tissue in contactwith the shielding extension 206.

An exemplary tip is described in more detail with respect to FIG. 3. Inthe example of FIG. 3, the tip 304 comprises the shielding extension306, a support extension 318, and a hollow conduit/cavity 316. Theconduit/cavity 316 prevents accidental contact with a laser guide orcrystal in the handpiece used for directing the light energy. Inaddition, in some embodiments, the length 303 of the conduit/cavity 316is configured as a distance guide to aid in maintaining a predetermineddistance between the surface tissue to be treated and a given crystal inthe handpiece. For example, the desired distance between the tissue tobe treated and the crystal in the handpiece is dependent on thetreatment to be applied and/or on the characteristics of the crystalselected. The length 303 of tip 304, therefore, is manufactured, in someembodiments, to vary from one tip to another tip. Thus, for a giventreatment and/or crystal, a tip 304 is selected which has a length 303that corresponds to the desired distance between the surface tissue andthe crystal for the given treatment and/or crystal. In anotherembodiment of the present invention, a laser light is delivered byhandpiece 102 to target tissue via free space and through a conduit inthe handpiece and conduit 316 of the tip 304. In this configuration theinternal surfaces of the handpiece conduit and the tip conduit 316 areconfigured to internally reflect the passing light and to minimizeenergy loss.

In some embodiments in which the length 303 varies from one to tip toanother, the length 301 between the shielding extension 306 and the tube316 is fixed for each tip. For example, the length 301 can be based onthe average thickness of an upper or lower adult eyelid. In otherembodiments, the length 303 is fixed from one tip to another and thelength 301 varies to correspond with desired distances between thesurface tissue and the conduit 316.

The shielding extension 306 is configured to be inserted between theocular conjunctiva and the palpebral conjunctiva and to extend to thefornix. Hence, the length 305 of the shielding extension 306 is based onan average depth of an adult fornix in some embodiments. In otherembodiments, the length 305 of the shielding extension can vary from onetip to another such that a medical professional can select a shieldingextension having a length appropriate for a given patient. Since theshielding extension extends to the fornix, the shielding extension 306is also referred to herein as a fornix shield.

In addition to the thermal properties discussed above, the shieldingextension 306 is configured to be sufficiently flexible that it can bedeformed to define irregular surfaces when inserted. For example, it candeform to the contours of the ocular tissue of a given patient. Thus,the shielding extension 306 is able to prevent energy not absorbed bythe target area from reaching tissue behind the target area. Inaddition, although the angle 307 between the shielding extension 306 andthe support extension 318 is depicted as a right angle in FIG. 3, it isto be understood that angle 307 is not limited to a right angle. Forexample, the angle 307 can change when tip 304 is used due to thedeformation of shielding extension 306. In addition, as shown in FIG. 4,the angle 407 formed between the shielding extension 406 and the supportextension 418 can be configured with an angle other than 90°.

In some embodiments, the shielding extension 506 may also be constructedfrom at least two layers, as shown in FIG. 5. Each layer 522-1 and 522-2has different characteristics. In one embodiment of the presentinvention, the first layer 522-1 is a proximal layer to the handpieceand the second layer 522-2 is a distal layer of the shielding extension506. The distal layer 522-2 is configured to be in direct contact withposterior organs to be protected such as cornea or scleara. The proximallayer 522-1 is configured to be in contact with the eyelid. In oneembodiment of the present invention, the distal layer 522-1 may havehigh thermal insulative properties while the proximal layer 522-2 mayhave high thermal conductivity properties and a low thermal capacity. Inthis configuration, the proximal layer 522-2 may be used to dissipatethermal energy passed through the eyelid and reach the shieldingextension 506. For example, the thermal energy can be dissipated via theshielding extension 506 and support extension 518 to a heat sinkreservoir located in the handpiece to which it is thermally coupled. Inyet another embodiment, the handpiece 102 may include a cooling sourcethermally coupled to the proximal layer 522-1 of the shielding extension506, in order to cool the target tissue. In this embodiment, the distalthermally insulative layer 522-2 isolates and protect posterior organsfrom cooling energy.

FIG. 6 depicts an exemplary tip 604 in operation to protect oculartissue. As shown in FIG. 6, the shielding extension 606 is insertedbehind the lower eyelid between the conjunctiva lining the lower eyelid(the palpebral conjunctiva) and the conjunctiva lining the sclera (theocular conjunctiva). The shielding extension 606 is being insertedtoward the fornix. Hence, the shielding extension 606 is able to protectthe sclera and the cornea from energy not absorbed by the target tissuein the lower eyelid. In addition, the shielding extension 606 issufficiently rigid that it can be used to apply a slight force thatseparates the lower eyelid from the sclera and cornea. Hence, a physicalgap is created between the lower eyelid and the sclera/cornea. Thisphysical gap acts as a thermal insulation barrier that providesadditional protection from thermal energy. Notably, although theshielding extension 606 is inserted behind the lower eyelid in thisexample, it is to be understood that the shielding extension 606 canalso be inserted behind the upper eyelid.

FIG. 7 is a flow chart depicting one embodiment of a method 700 ofprotecting ocular tissue. Method 700 is implemented using a handpiecehaving a tip with a shielding extension such as tip 304 described above.At block 702, a removable tip having a shielding extension is attachedto a handpiece. At block 704, the distal end of the tip is inserted tothe posterior side of an eyelid (e.g. the lower eyelid), in the areabetween the conjunctiva-covered sclera and the conjunctiva-coveredinferior eyelid, until it reaches the fornix, as described above. Atblock 706, a force is optionally exerted on the tip to pull thepalpebral area anteriorly, thereby creating a physical separation of theeyelid from the anterior surface of the eye globe. At block 708,external eye shielding, such as eye shielding described in U.S. Pat. No.7,886,748, is optionally applied over the non-treated areas of the skinin the ocular and/or periocular areas to provide a second layer ofprotection.

At block 710, the handpiece delivers light to the ocular and/orperiocular treatment areas, such as on an external surface of theeyelid. The handpiece is configured to generate the heat needed for agiven treatment. For example, the light can be used to treat a varietyof ophthalmic and/or dermatological conditions, such as but not limitedto, meibomian gland dysfunction (e.g. dry eye), wrinkles, and lesions inthe skin. The light applied by the handpiece is determined based on thecondition to be treated. For example, the heat generated to treatmeibomian gland dysfunction is generated at a level sufficient tostimulate the meibomian gland and/or decrease palpebral telangiectasia.Thus, the level of heat for treating meibomian gland dysfunction is notnecessarily the same as the level to remove wrinkles. In either case,the shielding extension provides thermal protection to the ocular tissuebehind the target treatment tissue. In addition, the physical separationcreated by force exerted on the tip adds another level of protection tothe ocular tissue. Thus, the embodiments of the tip described hereinprovide increased protection of ocular tissue. Furthermore, the tipsprovide a hygienic solution for protecting the sensitive ocular tissuedue to the single-use disposable characteristic of the tip in someembodiments.

Although specific embodiments have been illustrated and describedherein, it will be appreciated by those of ordinary skill in the artthat any arrangement, which is calculated to achieve the same purpose,may be substituted for the specific embodiments shown. Therefore, it ismanifestly intended that this invention be limited only by the claimsand the equivalents thereof.

What is claimed is:
 1. A method of treating meibomian gland dysfunctionby an application of thermal energy, the method comprising: providing ahandpiece having a thermal energy device at a distal end thereof;providing a tip on the distal end of the thermal energy device, the tiphaving a shielding extension configured to be inserted behind an eyelidand comprised of a thermally insulative material; inserting theshielding extension behind the eyelid; contacting the anterior surfaceof the eyelid with the tip prior to applying thermal energy to theanterior surface of the eyelid; applying thermal energy to the anteriorsurface of the eyelid; wherein heat from the thermal energy devicetreats meibomian gland dysfunction.
 2. The method of claim 1, furthercomprising the step in which shielding extension is manipulated tocreate a mechanical separation of the target tissue from adjacentposterior eye structures.
 3. The method of claim 1, wherein theshielding extension is configured to be sufficiently flexible such thatit deforms to conform to irregular eye structure surfaces when inserted.4. The method of claim 1, wherein the tip comprises a material that isbiocompatible with ocular tissue.
 5. The method of claim 1, wherein thehandpiece further comprises a heat sink thermally coupled to theshielding extension.
 6. The method of claim 1, wherein the handpiecefurther comprises a cooling source thermally coupled to the shieldingextension.
 7. The method of claim 1, wherein the thermal energy deviceis a light energy device.
 8. The method of claim 7, wherein the lightenergy device is scanned to deliver fractional energy treatment to theeyelid.
 9. The method of claim 1, wherein the thermal energy device isscanned to deliver fractional energy treatment to the eyelid.
 10. Adevice for treating meibomian gland dysfunction by an application ofthermal energy, the method comprising: a handpiece having a thermalenergy device at a distal end thereof; a tip on the distal end of thethermal energy device, the tip having a shielding extension configuredto be inserted behind an eyelid and comprised of a thermally insulativematerial; wherein: the shielding extension is inserted behind theeyelid, the anterior surface of the eyelid is contacted with the tipprior to applying thermal energy to the anterior surface of the eyelid,and thermal energy is applied to the anterior surface of the eyelid;whereby heat from the thermal energy device treats meibomian glanddysfunction.